Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN

Abstract

Introduction: To analyse the safety and effectiveness of gliclazide modified release (MR) in adults with type 2 diabetes mellitus participating in Ramadan from three geographically and culturally different regions of the world included in the DIA-RAMADAN study.

Methods: DIA-RAMADAN was a real-world, observational, international, non-comparative study. The global study population was divided into three regional subgroups, with data gathered at inclusion 6-8 weeks prior to Ramadan (V0), during Ramadan (4.5 weeks) and 4-6 weeks after Ramadan (V1). Primary endpoint was the proportion of patients reporting ≥ 1 symptomatic hypoglycaemic events (HE), which were collected using a patient diary along with other adverse events.

Results: Patient numbers from the three regions were n = 564 (46.5%; Indian sub-continent), n = 354 (29.1%; Middle East) and n = 296 (24.4%; South-East Asia). Patient baseline characteristics, demographics, fasting habits and antidiabetic treatments varied between regions. There were similar proportions of symptomatic HE between regions, with no severe HE. Significant weight reductions were observed in all regions following Ramadan, along with reductions in HbA_1c and fasting plasma glucose.

Conclusion: These real-world study data indicate that gliclazide MR is safe and effective for management of type 2 diabetes during Ramadan in all three regions studied as part of DIA-RAMADAN.

Trial registration: Clinicaltrials.gov identifier NCT04132934. INFOGRAPHIC.

Keywords: Diabetes mellitus; Fasting; Gliclazide; Ramadan; Type 2.

Fig. 1

Antidiabetic treatments in the three regions. DPP4i dipeptidyl peptidase 4 inhibitor, GLP1 RA glucagon-like peptide 1 receptor agonist, SGLT-2i sodium glucose cotransporter 2 inhibitor, MR modified release, TZD thiazolidinedione

Fig. 2

a Change in weight between V0 and V1 (mean [kg] ± SD). Mean change was calculated based on patients with values available at V0 and V1. b Change in HbA_1c between V0 and V1 (mean [%] ± SD). Mean change was calculated based on patients with available data at V0 and V1. c Change in FPG between V0 and V1 (mean [mg/dl] ± SD). Mean change was calculated based on patients with values available at V0 and V1. P values were calculated with rank signed test (weight) and Student’s t test (HbA_1c and FPG). FPG fasting plasma glucose, HbA_1c glycosylated haemoglobin, SD standard deviation, V0/1 study visit 0/1